Medical device and methods of use

ABSTRACT

The present disclosure is directed to a medical device. Systems and methods are provided for utilizing a laser to break a kidney stones into smaller fragments and/or dust, and removing particles, stone fragments and/or stone dust from a patient. The medical device may include a delivery device including a tube, and an elongate member having a distal end, a proximal end, and a lumen extending between the proximal end and the distal end, wherein the elongate member is configured to move axially relative to the tube and apply suction through the distal end.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62/288,734, filed Jan.29, 2016, which is herein incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to medical devices. Moreparticularly, the disclosure relates to medical devices used, forexample, in breaking objects into smaller particles, and removing theresulting particles from a patient. The disclosure also relates tomethods of using such devices.

BACKGROUND

The incidence of hospitalization for the removal of urinary calculi,commonly referred to as kidney stones, has been estimated at 200,000cases per year. A vast majority of these patients pass their stonesspontaneously; however, in the remainder, the kidney stone(s) becomeimpacted in the ureter, a muscle tube joining the kidney to the bladder.An impacted kidney stone is a source of intense pain and bleeding, asource of infection and, if a stone completely blocks the flow of urinefor any extended length of time, can cause the loss of a kidney.

Recently, various methods have been utilized to break the stone intosmaller fragments. One such method is stone dusting. Stone dusting isused by some urologists to fragment and evacuate stones from a kidneyand is often performed by a ureteroscope. Intense light energy from alaser within the ureteroscope breaks the stone into increasingly smallerpieces. However, in some cases, the stone and/or the stone fragments maybe pushed away from the ureteroscope by the laser, thus making itimpossible to continue to break the stone or stone fragments intosmaller fragments without repositioning the ureteroscope. The disclosureaddresses the above-mentioned process and other problems in the art.

Further, rather than breaking up the stone into chunks, which areremoved by baskets, dusting generates very small fragments that arecapable of being passed naturally. However, in some cases, these smallstone fragments may not pass naturally. For example, the stone fragmentsmay collect in an area of the kidney where they are less likely to flowout naturally, such as the lower calyx of the kidney. In theory, any ofthese small stone fragments that do not evacuate through natural urineflow, could be a seed for new stone growth. Thus, the application ofsuction may be employed to remove the stone dust. Breaking up a stoneand providing suction requires a working channel with a sufficientinternal cross-sectional area to receive a laser fiber and a lumen withsufficient internal cross-sectional area to allow stone fragments and/ordust to pass through without clogging. The combined cross-sectionalareas of these two elements may make a device too large to reach thetarget kidney stone. For example, the kidney stone may be within thekidney, or, specifically, within the lower calyx of the kidney. Often,the space within the kidney and/or lower calyx of the kidney is morelimited than the space within the ureter and this space may not be largeenough to accommodate both a working channel for a laser fiber and alumen for applying suction. The disclosure addresses the above-mentionedprocess and other problems in the art.

SUMMARY OF THE DISCLOSURE

Aspects of the present disclosure provide device and methods forbreaking an object into smaller particles and removing said particlesfrom portions of the human body.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive.

In one example, a medical device may include a delivery device includinga tube, and an elongate member having a distal end, a proximal end, anda lumen extending between the proximal end and the distal end, whereinthe elongate member is configured to move axially relative to the tubeand apply suction through the distal end.

Examples of the medical device may additionally and/or alternativelyinclude one or more other features. Features of the various examplesdescribed in the following may be combined unless explicitly stated tothe contrary. For example, the proximal end of the elongate member maybe forked. The proximal end of the elongate member may be connected to acontrol system. The control system may control the vacuum source. Theproximal end of the elongate member may be in fluid communication with avacuum source. The medical device may include a sleeve, wherein thesleeve may be configured to receive the tube and the elongate membersimultaneously. The delivery device may be one of ureteroscope, sheath,catheter, or endoscope. The medical device may include a laser fiberconnected to the tube. The lumen of the elongate member may besubstantially D-shaped. The tube may include an illumination device. Thetube may include an imaging device. The tube may have a first engagingsurface, and the elongate member may have a second engaging surface, andthe first engaging surface may be substantially complementary of thesecond engaging surface. The elongate member may be in fluidcommunication with a fluid source. The lumen of the elongate member mayhave an inner diameter of approximately 1 mm to approximately 3.5 mm.The elongate member may be at least partially controlled by a controlsystem and the tube may be at least partially controlled by a handle.

In another example, a method operating a medical device may includepositioning a distal end of an elongate member of the medical device ata target area, applying suction through a lumen of the elongate memberto seal an object to the distal end of the elongate member, and movingthe distal end of the elongate member to move the object sealed to thedistal end of the elongate member.

Examples of the method of operating the medical device may additionallyand/or alternatively include one or more other features. For example,prior to positioning the distal end of the elongate member of themedical device at the target area, the method may include positioningthe distal end of the elongate member proximal to the target area, andsupplying dye through the lumen of the elongate member to the distal endof the elongate member. The method may include moving the objectproximate to a tube, disposing a laser fiber within the tube, andinitiating the laser.

In another example, a method operating a medical device may includepositioning a distal end of an elongate member of the medical devicedistal to a distal end of a tube of the medical device, applying suctionthrough a lumen of the elongate member to seal a kidney stone to thedistal end of the elongate member, and moving the distal end of theelongate member to move the kidney stone sealed to the distal end of theelongate member proximally toward the distal end of the tube.

Examples of the method of operating the medical device may additionallyand/or alternatively include one or more other features. For example,the method may include disposing a laser fiber within the tube, andinitiating the laser.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various examples and togetherwith the description, serve to explain the principles of the disclosure.

FIG. 1 illustrates an exemplary medical device, including a tube, anelongate member, a handle portion, a control system, and a sleeve;

FIG. 2A illustrates an exemplary distal end of the medical device ofFIG. 1 with the elongate member in a retrieval position;

FIG. 2B illustrates an exemplary distal end of the medical device ofFIG. 1 with the elongate member in an operating position;

FIG. 3A illustrates an exemplary cross-section of the medical devicetaken at 3-3 of FIG. 1;

FIG. 3B illustrates an alternative exemplary cross-section of themedical device taken at 3-3 of FIG. 1;

FIG. 4 illustrates an exemplary connection between a proximal end of theelongate member and the control system of FIG. 1;

FIGS. 5A-C illustrates an exemplary method of operation of the medicaldevice of FIG. 1; and

FIG. 6 is a block diagram of an exemplary method of using the medicaldevices disclosed herein.

DETAILED DESCRIPTION

Reference is now made in detail to examples of the present disclosure,examples of which are illustrated in the accompanying drawings. Whereverpossible, the same reference numbers will be used throughout thedrawings to refer to the same or like parts. The term “distal” refers toa position farther away from a user end of the device. The term“proximal” refers a position closer to the user end of the device. Asused herein, the terms “approximately” and “substantially” indicate arange of values within +/−5% of a stated value.

Overview

Aspects of the present disclosure relate to systems and methods forbreaking kidney stones into smaller particles and removing thoseparticles from a target area of a patient's body. The medical devicedescribed herein may work by securing an elongate member for suction toan outer surface of a tube of a delivery device. A distal end of thetube and a distal end of the elongate member may be positioned within aureter of a patient. In some examples, radiopaque dye may be injectedinto the target area, e.g., the kidney, from a lumen of the elongatemember. Then, the elongate member may be extended distally to aretrieval position in which the distal end of the elongate member ispositioned within the target area, e.g., the lower calyx of the kidney,and/or proximate the target kidney stone. Suction may be applied throughthe elongate member, pulling the stone toward a distal opening of theelongate member until the stone contacts and forms a seal with thedistal opening of the elongate member. The formed seal secures thekidney stone to the distal opening of the elongate member. With thestone secured to the elongate member, the elongate member may beretracted or pulled proximally toward the distal end of the tube untilthe elongate member is in the operating position, e.g., the securedstone is proximate a distal opening of the tube. At this point, a laserfiber, disposed within the tube, may be used to break up kidney stonesinto particles. It should be noted that the stone may be broken intoparticles in any way known in the art, including the application ofultrasound and/or sound waves on the stone. Once the stone is brokeninto particles that are smaller than the distal opening the elongatemember, the seal may be broken and/or particles may be suctioned intothe lumen of the elongate member. These particles may be vacuumedthrough the elongate member and out of the patient's body.

DETAILED EXAMPLES

FIG. 1 illustrates medical device 100 for removing stones from apatient's body. Medical device 100 may include a retrieval system. Theretrieval system may include elongate member 202 and control system 210.Elongate member 202 may be a hollow, flexible, elongate tube having adistal end 204 and a proximal end 206 and at least one lumen (e.g.,lumen 214 of FIGS. 2A-B) extending therebetween. Proximal end 206 ofelongate member 202 may be coupled to control system 210, vacuum source250, and/or fluid source 280. As shown in FIG. 1, medical device 100 mayinclude a delivery device. The delivery device may be, for example, anytraditional delivery device, including a ureteroscope, sheath, catheter,endoscope, etc. The delivery device may include a tube 102 and a handleportion 110. Tube 102 may be a hollow, flexible, elongate tube having adistal end 104 and a proximal end 106 and at least one lumen (e.g.,lumen 112 of FIGS. 2A-B) extending therebetween. Proximal end 106 oftube 102 may be coupled to handle portion 110. The handle portion 110and/or the proximal end 106 of tube 102 may be attached to a lasercontrol 130 and/or a fluid supply assembly 140. In some examples,medical device 100 may include a sleeve 302 and fastener 136. Sleeve 302and fastener 136 may be any mechanism known in the art for allowingelongate member 202 (and/or the entirety of the retrieval device) tomove axially relative to tube 102 and prevent radial movement ofelongate member 202 relative to tube 102.

Depending upon the particular implementation and intended use, thelength of tube 102, elongate member 202, and/or sleeve 302 may vary. Inthe example shown in FIG. 1, sleeve 302 may be shorter in length thantube 102 and elongate member 202. Depending upon the particularimplementation and intended use, tube 102, elongate member 202, and/orsleeve 302 can be rigid along its entire length, flexible along aportion of its length, or configured for flexure at only certainspecified locations. In one example, tube 102, elongate member 202,and/or sleeve 302 may be flexible, adapted for flexible steering withinbodily lumens, as understood in the art. For example, tube 102 caninclude a steering system (not shown) to move at least a portion (e.g.,distal end 104) up/down and/or side-to-side. Additional degrees offreedom, provided for example via rotation, translational movement oftube 102, or additional articulation of bending sections, may also beimplemented. Examples of such steering systems may include at least oneof or more of pulleys, control wires, gearing, and electrical actuators.

Tube 102, elongate member 202, and/or sleeve 302 may be formed of anysuitable material having sufficient flexibility to traverse bodycavities and tracts. In general, tube 102, elongate member 202, and/orsleeve 302 may be made of any suitable material that is compatible withliving tissue or a living system. That is, tube 102, elongate member202, and/or sleeve 302 may be non-toxic or non-injurious, and it shouldnot cause immunological reaction or rejection. In some examples, tube102, elongate member 202, and/or sleeve 302 may be made of polymetricelastomers, rubber tubing, and/or medically approved polyvinylchloridetubing. Polymeric elastomers may be, for example, EVA (Ethylene vinylacetate), silicone, polyurethane, and/or C-Flex.

Further, tube 102, elongate member 202, and/or sleeve 302 may includeany suitable coating and/or covering. For example, the outer surface mayinclude a layer of lubricous material to facilitate insertion through abody lumen or through sleeve 302. Further, tube 102, elongate member202, and/or sleeve 302 may be coated with a biocompatible material suchas Teflon. To inhibit bacterial growth in the body cavity, tube 102,elongate member 202, and/or sleeve 302 may be coated with anantibacterial coating. Further, an anti-inflammatory substance may alsobe applied to the outer surface of the tube 102, elongate member 202,and/or sleeve 302, if required.

Tube 102, elongate member 202, and/or sleeve 302 may be designed toimpose minimum risk to the surrounding tissues while in use. To thisend, one or more portions of tube 102, elongate member 202, and/orsleeve 302 may include atraumatic geometrical structures, such asrounded or beveled terminal ends or faces (e.g., distal end 104 of tube102), to reduce trauma and irritation to surrounding tissues.

I. Sleeve

Sleeve 302 may be hollow and configured to slidably receive tube 102 andelongate member 202 simultaneously. Tube 102 may be circular, ovoidal,irregular, and/or any shape suitable to enter a body and/or receive tube102 and elongate member 202. In some examples, a lumen running throughsleeve 302 may be shaped to accommodate the size and shape of tube 102and elongate member 202. In other examples, the lumen may besubstantially circular and sleeve 302 may be made of elastic material tostretch to accommodate the size and shape of the combination of tube 102and elongate member 202. A lumen extending through sleeve 302 mayinclude any suitable coating. For example, the lumen may include a layerof lubricous material, for example, to facilitate insertion of tube 102and elongate member 202.

II. Delivery Device

As previously described, medical device 100 may include a deliverydevice. The delivery device may be, for example, any delivery deviceknown in the art, including ureteroscope, sheath, catheter, endoscope,etc. The delivery device may include a tube 102 and a handle portion110.

A. Handle Portion

Handle portion 110 can be attached to proximal end 106 of tube 102 by,for example, welding, a locking configuration, use of an adhesive, orintegrally forming with tube 102. The handle portion 110 may include aplurality of ports. For example, a first port may supply to distal end104 of tube 102 a laser fiber (e.g., laser fiber 120) coupled to lasercontrol (e.g., laser control 130). In some examples, a second port mayplace lumen 112 in fluid communication with a fluid supply assembly(e.g., fluid supply assembly 140). Additional ports and lumens may beprovided for supplying and/or controlling an illumination device and/oran imaging device located at or near distal end 104 of tube 102. Thehandle portion 110 may include an actuating mechanism (not shown) toactuate one or more medical devices that may be located at the distalend 104 of tube 102. For example, handle portion 110 may include anactuating mechanism to power on or off the laser, the illuminationdevice, and/or the imaging device.

B. The Tube

Tube 102 may be circular, ovoidal, irregular, and/or any shape suitableto enter a body. Further, tube 102 may have a uniform shape along itslength, or may having a varying shape, such as a taper at the distal endto facilitate insertion within the body. In some embodiments of thepresent disclosure, the distal end 104 of tube 102 includesvisualization devices such as a camera and/or a light source. Thesedevices may attach to the distal end 104 using known couplingmechanisms. Alternatively, the visualization devices may be detachablyintroduced into tube 102 through lumen 112 (or a separate lumen, e.g.,lumen 124 or 126 of FIGS. 2A-B) when required.

Lumen 112 may be defined by an elongate hollow lumen that extendsbetween proximal end 106 and distal end 104 of tube 102. Lumen 112 maybe any size, shape, and/or in any configuration within tube 102.Exemplary cross-sections of tube 102 and lumen 112 will be described infurther detail below with respect to FIGS. 3A and 3B.

III. Retrieval System

As previously described, medical device 100 may include a retrievalsystem. The retrieval system may include elongate member 202 and controlsystem 210.

A. The Elongate Member

Elongate member 202 may be circular, ovoidal, irregular, and/or anyshape suitable to enter a body and/or sleeve 302. Further, elongatemember 202 may have a uniform shape along its length, or may having avarying shape, such as a taper at the distal end to facilitate insertionwithin the body. In some embodiments of the present disclosure, thedistal end 204 of elongate member 202 includes reinforced section 226.The walls of reinforced section 226 may be thicker than the remainder ofelongate member 202. This may prevent distortion of the reinforcedsection 226 when a stone is vacuumed and held against a distalopening/distal end 204 (as described in further detail below withrespect to FIGS. 5A-C).

Lumen 214 may be defined by an elongate hollow lumen that extendsbetween proximal end 206 and distal end 204 of elongate member 202.Lumen 214 may be any size, shape, and/or in any configuration withinelongate member 202. For example, the inner diameter of lumen 214 may beapproximately 1 mm to approximately 3.5 mm, approximately 1.5 mm toapproximately 3 mm, or approximately 2 mm to approximately 3 mm.Exemplary cross-sections of elongate member 202 and lumen 214 will bedescribed in further detail below with respect to FIGS. 3A and 3B.

In some examples, elongate member 202 may act as a guidewire to guideattached tube 202. For example, elongate member 202 may be inserted intothe body before the insertion of tube 102, and tube 102 may be trackedalong an outer surface (e.g., engaging surface 284) of elongate member202 in order to position tube 102 within the body. It should be notedthat any of lumens 112 or 214 may additionally or alternatively beconfigured to receive a guidewire. In some embodiments, lumen 214 mayreceive a guidewire to facilitate positioning elongate member 202 in thebody.

To effectively maneuver the elongate member 202 within a body cavityand, for example, position distal end 204 proximate of a kidney stonewithin a lower calyx of a kidney, an operator may need to know the exactlocation of the elongate member 202 in the body. To this end, one ormore portions of elongate member 202 may be made of radiopaque, such asby inclusion of barium sulfate in plastic material or inclusion of oneor more metal portions, which provide sufficient radiopacity. In someexamples, elongate member 202 may have a radiopaque coating.Additionally or alternatively, distal end 204 of elongate member 202 mayinclude radiopaque or sonoreflective markers (not shown). These markingsfacilitate detection of a position and/or orientation of elongate member202 within a patient's body, and an operator, with the aid of suitableimaging equipment, may track the path followed by elongate member 202.This may help the operator avoid potential damage to sensitive tissues.By using fluoroscopic guidance, elongate member 202 may be locatedwithout the visualization devices within tube 102 and, therefore, moveindependently of and/or not within the field of view of thesevisualization devices. Further, with such guidance, the space withinelongate member 202 that would be needed for direct visualization (e.g.,an imaging apparatus) may instead be used to maximize the size of thelumen and/or the flow rate of the suction.

FIGS. 2A-B illustrate exemplary distal ends of medical device 100 withelongate member 202 in a retrieval position and an operating position,respectively. As shown in FIG. 2A, in a retrieval position, distal end204 of elongate member 202 may be distal of the distal end 104 of tube102. In an operating position, as shown in FIG. 2B, distal end 204 ofelongate member 202 may be closer to and/or flush with the distal end104 of tube 102.

FIG. 3A illustrates a cross-sectional view of an exemplary medicaldevice 100. This view may, for example, be at line 3-3 of FIG. 1. Asshown, tube 102 may include a lumen 112, illumination device 126,imaging apparatus 124, and/or engaging surface 184. Lumen 112 may besemi-circular in shape. Lumen 112, however, may have any cross-sectionalsize and/or shape. In the example shown in FIG. 3A, engaging surface 184may be substantially planar. Engaging surface 184 is not limited theretoand may have shape, including any shape that is substantiallycomplementary with an engaging surface of an elongate member (e.g.,engaging surface 284 of tube 202). For example, as shown in FIG. 3A,elongate member 202 has a substantially planar engaging surface 284.Lumen 214 of elongate member 202 may be substantially D-shaped, however,lumen 214 is not limited thereto and may have any cross-sectional sizeand/or shape. FIG. 3A shows a space between engaging surface 284 ofelongate member 202 and engaging surface 184 of tube 102. In someexamples, however, gravity may pull and/or sleeve 302 may push engagingsurface 284 of elongate member 202 to contact engaging surface 184 oftube 102. Sleeve 302 should be configured to avoid so much friction asto restrict axial movement of elongate member 202 relative to tube 102.Spaces 304 are spaces between an interior wall of sleeve 302 and theouter surfaces of elongate member 202 and/or tube 102. In some examples,these spaces may be minimized, for example, if sleeve 302 is made of anelastic material configured to “hug” on the outer surfaces of elongatemember 202 and/or tube 102.

FIG. 3B illustrates a cross-sectional view of an alternative exemplarymedical device 100. This view may, for example, be at line 3-3 ofFIG. 1. As shown, the cross-sectional area of elongate member 202′ andlumen 214′ of elongate member 202′ are substantially circular. Tube 102includes a lumen 112, illumination device 126, imaging apparatus 124,and/or engaging surface 184′. Engaging surface 184′ is substantiallyconcave and may be substantially complementary to an outer surface ofelongate member 202′.

It should be noted that in some examples, elongate member 202 and/orelongate member 202′ may be configured to engage (and/or slide across)an outer surface of a conventional or substantially circular deliverydevice. In such examples, engaging surface 284 and/or 284′ may beconcave and/or be complementary with the outer surface of asubstantially circular delivery device.

B. Control System

FIG. 4 is an enlarged exemplary view of proximal end 206 of elongatemember 202 and control system 210. Distal of proximal end 206, elongatemember 202 may fork, for example, into first end 214 and second end 244.First end 244 of elongate member 202 may be open and configured toattach to, for example any fluid source known in the art, e.g., a fluidsource 280 of FIG. 1. For example, dye or, more specifically, radiopaquedye may be within fluid source 280.

Second end 214 of elongate member 202 may attach to control system 210by, for example, a locking configuration, use of an adhesive, orintegrally forming with elongate member 202. Control system 210 mayallow an operator to control operation of the retrieval system. Forexample, as described in further detail below, control system 210 mayinclude the ability to control steering of elongate member 202,introduce dye into elongate member 202, and/or apply suction throughelongate member 202. In some examples, control system 210 may include orbe in fluid communication with a vacuum source, e.g., vacuum source 250of FIG. 1. A vacuum source may include a house vacuum, vacuum pump,compressor unit, etc. Control system 210 may include any input devicesknown in the art, including buttons, switches, keyboards, dials,touchscreens, etc. Input device 230 may, for example, be an on-offbutton to turn on or off the vacuum source and either apply or ceaseapplication of suction from distal end 204 of elongate member 202. Inputdevice 230 may be a dial for adjusting the flow rate of this suction.

IV. Insertion and Operation of the Medical Device

FIG. 5A-C illustrate an exemplary method of operation of medical device100, including an enlarged view of upper ureter 406 and lower calyx 410of kidney 408. Kidney stones 470 and 472 are located in lower calyx 410.As previously mentioned, the space within calyx 410 of kidney 408 isoften more limited than the space within the ureter 406.

An operator (e.g., a doctor or other medical professional) may connectelongate member 202 and tube 102 by sliding their respective distal endsthrough a proximal opening of sleeve 302. In some examples, medicaldevice 100 may be pre-assembled and this step may omitted. In someexamples, one or both of tube 102 and elongate member 202 may beseparately or simultaneously inserted into patient's urethra, throughthe urinary bladder, and into ureter 406. In examples in which elongatemember 202 is used as a guidewire, distal end 204 of elongate member 202may be inserted into a patient's urethra, through the urinary bladder,and into ureter 406. In some examples, once distal end 204 of elongatemember 202 is positioned within the upper ureter, an operator mayinitiate the introduction of fluid into kidney 408 through lumen 214 ofelongate member 202. For example, a fluid source (e.g., fluid source 280of FIG. 1) may be fluidly connected to first end 244 of elongate member202 and fluid may be transmitted through first end 244, through lumen214 of elongate member 202, to distal end 204 of elongate member 202,and into the kidney 408. In some examples, the fluid may be radiopaquedye. As shown in FIG. 5A, dye 550 may enter the ureter 406 and/or kidney408 (depending on the location of distal end 204 of elongate member 202)and may disperse throughout kidney 408 and/or lower calyx 410. This mayallow the operator to determine the location of any kidney stones withinthe kidney. The introduction of any fluid (e.g., not limited toradiopaque) into the kidney may at least partially inflate the kidney,thus providing additional space to perform the desired procedure.Further, the introduction of fluid as an initial step may ensure thatthe pressure within the kidney remains at a sufficient level, e.g., thekidney will not collapse, once suction is applied to the kidney throughlumen 214 of elongate member 202 (as described in further detail below).It should be noted that in some examples, fluid is not introducedthrough lumen 214 of elongate member 202, and once disposed with thepatient's body, an operator may proceed to the next step, e.g., locatingand securing a kidney stone.

Elongate member 202 may be extended distally into kidney 408, so thatthe distal opening of lumen 214 is proximate to kidney stone 470. Atthis point, elongate member 202 is in a retrieval position, e.g., distalend 204 of the elongate member 202 is positioned distal of distal end104 of tube 102. An operator may initiate a vacuum source, e.g., byselecting input device 230 of FIG. 4, to apply suction through lumen 214to distal end 204 of elongate member 202. Suction into lumen 214 ofelongate member 202 may pull the stone toward a distal opening ofelongate member 202 until the stone contacts and forms a seal with thedistal opening of elongate member 202. The formed seal may secure thekidney stone to the distal opening of the elongate member 202. As shownin FIG. 5B, with the stone secured to elongate member 202, elongatemember 202 may be retracted or pulled proximally toward ureter 406and/or distal end 104 of tube 102 until the elongate member is in theoperating position, e.g., secured stone 470 is proximate a distalopening of tube 102. At any time between the insertion of elongatemember 202 into the patient and the above step of securing the stoneproximate the distal opening of tube 102, tube 102 may track elongatemember 202 like a guidewire, so that distal end 104 is positioned withinureter 406. FIG. 5C illustrates an operating position of elongate member202 in which distal end 204 of elongate member 202 is closer to distalend 104 of tube 102 than in the retrieval position.

As shown in FIG. 5C, once the laser fiber 120 is in a sufficientposition to aim for secured kidney stone 470, the operator may initiatethe laser to break up kidney stone 470. Laser fiber 120 may beintroduced into a patient through lumen 112 of tube 102. Laser fiber 120may be connected to and/or controlled by laser control 130. (It shouldbe noted that the stone may be broken into particles in any way known inthe art, including the application of ultrasound and/or sound waves onthe stone.) Once stone 470 is broken into particles that are smallerthan the cross-sectional area of the distal opening of elongate member202, the seal may be broken and/or particles may be suctioned into lumen214 of elongate member 202. These particles may be vacuumed throughelongate member 202 and out of the patient's body. The stone particlesare suctioned out from lumen 214 of elongate member 202 along with theused saline fluid and collect in the chamber outside the patient bodythrough the saline outlet pathway.

The application of suction through lumen 214 of elongate member 202 mayimprove the ability to break kidney stones by creating ananti-retropulsion effect. By applying suction through lumen 214, akidney stone may be pulled toward laser fiber 120, thus countering theeffect of the laser energy pushing the kidney stone away. Thisconfiguration thus assists in generating the smaller stone fragments bypulling the stones into the reach of laser fiber 120.

Once the operator determines a sufficient amount of the resultingparticles of stone 470 have been removed from the patient's body or doesnot want to continue for other reasons, the laser process and/orapplication of suction may be stopped. At any point, an operator mayadditionally choose to move the device within the patient. For example,an operator may choose repeat the process. In FIG. 5C, elongate member202 has secured a first kidney stone 470, but a second kidney stone 472remains within lower calyx 410. Once kidney stone 470 has been removedfrom the patient's body, the operator may move distal end 204 ofelongate member 202 to a retrieval position and position its distalopening proximate to kidney stone 472. The above process may then berepeated for securing, moving, and breaking up stone 472. An operatormay reposition any element of the medical device and/or repeat any ofthe above described steps any number of times. Once an operatordetermines no more kidney stones can and/or should be broken apartand/or no more stone fragments/dust can and/or should be removed,medical device 100 may be removed from the patient's body.

FIG. 6 illustrates an exemplary method of use of a medical device forremoval of stone fragments/dust. For purposes of discussion, method 600will be described using medical device 100 of FIG. 1 and the urinarysystem of FIGS. 5A-C, as described above, but method 600 is not intendedto be limited thereto. As shown in FIG. 6, method 600 includes steps602, 604, 606, 608, 610, 612, and 614. However, it should be noted thatmethod 600 may include more or fewer steps as desired for a particularimplementation and the order of the steps may be varied.

Method 600 may commence after elongate member 202 and/or tube 102 ofmedical device 100 have been inserted into a patient's body. In step602, distal end 204 of elongate member 202 may be positioned proximal ofa target area (e.g., kidney 408 and/or lower calyx 410). In step 604, asillustrated in FIG. 5A, dye (e.g., dye 550) may be supplied through alumen (e.g., lumen 214) of the elongate member (e.g., elongate member202) to the distal end (e.g., distal end 204) of the elongate member. Instep 606, distal end 204 of elongate member 202 may be positioned at thetarget area (e.g., kidney 408 and/or lower calyx 410) and/or distal ofdistal end 104 of tube 102. Once distal end 204 of elongate member 202is proximate an object (e.g., kidney stone 470), method 600 may proceedto step 608 and suction may be applied through lumen 214 of elongatemember 202. An operator may apply suction to lumen 214 of elongatemember 202 by, for example, initiating vacuum source 250 of FIG. 1. Theapplication of suction may move the object to the distal opening oflumen 214 and the object (e.g., kidney stone 470) may form a seal withdistal end 204 of elongate member 202. In some examples, distal end 204of elongate member 202 may be repositioned in order to capture theobject with the applied suction. Once a seal is formed, method 600 mayproceed to step 610. In step 610, distal end 204 of elongate member 202may be moved distally and/or proximate to distal end 104 of tube 102, asshown in FIG. 5B. Moving distal end 204 of elongate member 202 may alsomove the object (e.g., kidney stone 470) distally and/or proximate todistal end 104 of tube 102. In step 612, once the object is proximate todistal end 104 of tube 102, a laser fiber may be disposed within thetube. For example, laser fiber 120 may extend through lumen 112 todistal end 104 of tube 102 and may aim at kidney stone 470. In step 614,the laser may be initiated. For example, an operator may initiate thelaser through laser control 130 and/or handle portion 110 of FIG. 1.

The many features of the disclosure are apparent from the detailedspecification, and thus, it is intended by the appended claims to coverall such features of the disclosure which fall within the true spiritand scope of the disclosure. Further, since numerous modifications andvariations will readily occur to those skilled in the art, it is notdesired to limit the disclosure to the exact construction and operationillustrated and described, and accordingly, all suitable modificationsand equivalents may be resorted to, falling within the scope of thedisclosure.

Other embodiments of the disclosure will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

What is claimed is:
 1. A medical device, comprising: a sleeve; adelivery device including a tube; and a member having a distal end, aproximal end, and a lumen extending between the proximal end and thedistal end, wherein the lumen of the member is D-shaped with a flat sideand a rounded side extending from opposing ends of the flat side,wherein the tube and the member are at least partially positioned withinand longitudinally movable relative to the sleeve, wherein the tube andthe member are positioned parallel to each other within the sleeve suchthat at least a portion of a circumferential exterior of the tube abutsa portion of a circumferential exterior of the member, and wherein themember is configured to move axially relative to the tube and applysuction through the distal end.
 2. The medical device of claim 1,wherein the proximal end of the member is forked.
 3. The medical deviceof claim 1, wherein the proximal end of the member is connected to acontrol system.
 4. The medical device of claim 3, wherein the controlsystem controls a vacuum source.
 5. The medical device of claim 1,wherein the proximal end of the member is in fluid communication with avacuum source.
 6. The medical device of claim 1, wherein the deliverydevice is one of ureteroscope, sheath, catheter, or endoscope.
 7. Themedical device of claim 1, further comprising: a laser fiber connectedto the tube.
 8. The medical device of claim 1, wherein the tube includesan illumination device and an imaging device.
 9. The medical device ofclaim 1, wherein the tube has a first engaging surface, the member has asecond engaging surface, and the first engaging surface is complementaryof the second engaging surface.
 10. The medical device of claim 9,wherein the member is D-shaped with a D-shaped circumferential exterior,with the second engaging surface being flat, and with a curved surfaceextending from opposite sides of the second engaging surface, whereinthe first engaging surface on the tube is flat, and wherein the tubeincludes a partially circular portion extending from opposite sides ofthe first engaging surface.
 11. The medical device of claim 1, whereinthe member is in fluid communication with a fluid source.
 12. Themedical device of claim 1, wherein the lumen of the member has an innerdiameter in the range of 1 mm to 3.5 mm.
 13. The medical device of claim1, wherein the member is at least partially controlled by a controlsystem and the tube is at least partially controlled by a handle,wherein the member is coupled to a suction source, and wherein themember is longitudinally movable relative to the tube and is configuredto extend distally beyond the tube to apply suction to an object at afirst position and retract proximally to bring the object to a secondposition closer to a distal end of the tube.
 14. A medical device,comprising: a sleeve; a delivery device including a tube having a distalend, a proximal end, and a lumen extending between the proximal end andthe distal end, wherein the tube includes a first flat portion; and amember having a distal end, a proximal end, and a lumen extendingbetween the proximal end and the distal end, wherein the member includesa second flat portion, and wherein the lumen of the member includes aD-shaped cross-section with a flat side and a rounded side extendingfrom opposing ends of the flat side, wherein the tube and the member arepositioned adjacent to each other at least partially within the sleevesuch that the first flat portion of the tube abuts the second flatportion of the member, and wherein the member is movable from at least afirst position where the distal end of the member is aligned with thedistal end of the tube to a second position where the distal end of themember is distally beyond the distal end of the tube.
 15. The medicaldevice of claim 14, wherein the member is D-shaped with acircumferential exterior having a D-shaped cross-section with a curvedsurface extending from opposite sides of the second flat portion,wherein the tube includes a partially circular portion extending fromopposite sides of the first flat portion, and wherein the lumen throughthe tube is semicircular.
 16. The medical device of claim 15, furtherincluding a laser element positioned within the lumen of the tube,wherein the laser element is longitudinally moveable within the lumen ofthe tube to extend distally beyond the distal end of the tube.
 17. Amedical device, comprising: a sleeve; a delivery device including a tubeat least partially positioned within the sleeve and having a distal end,a proximal end, and an lumen extending between the proximal end and thedistal end; a member at least partially positioned within the sleeve andpositioned adjacent to the tube, wherein the member includes a distalend, a proximal end, and a lumen extending between the proximal end andthe distal end, wherein the lumen of the member includes a D-shapedcross-section with a flat side and a rounded side extending fromopposing ends of the flat side; and a laser element movably positionedwithin the lumen of the tube, wherein the tube and the member arepositioned adjacent to each other within the sleeve, wherein the tubeand the member are longitudinally movable relative to the sleeve, andwherein the laser element is extendable distally beyond the distal endof the tube.
 18. The medical device of claim 17, wherein the tubeincludes a first flat portion, wherein the member includes a second flatportion, and wherein the first flat portion of the tube abuts the secondflat portion of the member.
 19. The medical device of claim 18, whereinthe member is movable from at least a first position where the distalend of the member is aligned with the distal end of the tube to a secondposition where the distal end of the member is distally beyond thedistal end of the tube.